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Monday, March 30, 2026
TopicDCGI

Topic: DCGI

No local clinical trial waiver despite change in rules, drugmakers knock on health ministry’s door

Drug regulator through executive order issued last August paved way for direct launch of certain categories of drugs approved in select countries by means of local clinical trials waiver.

India has a substandard, fake drugs problem. Lack of recall law, scrutiny is making matters worse

Underlining need for more accountability, experts also stress that govt data does not include fixed dose combination drugs, which account for over 40% of drugs sold in India.

‘Unauthorised promotion’, risk of unsafe use: Why CDSCO revoked nod for eye drops to replace glasses

Drugs Controller General of India, who heads CDSCO, says Entod pharma failed to reply satisfactorily to queries raised. Entod to challenge suspension of approval.

Why apex ophthalmologists’ body wants to review new eye drops designed to replace reading glasses

All India Ophthalmological Society has set up expert group to review PresVu & develop guidelines on side-effects, keeping in mind 'potential inappropriate marketing, indiscriminate use'.

Launched in India: eye drop that can replace your reading glasses

Launched Tuesday by Entod Pharmaceuticals under brand name PresVu, eye drop will treat presbyopia, an age-related condition causing blurry vision. To be available across India by October.

Govt notifies rule for rapid launch of breakthrough drugs in India, bypassing local clinical trials

In an executive order, the DGCI has specified a list of countries under rule 101 of New Drugs and Clinical Trials Rules, 2019. List includes US, UK & EU, among others.

Breakthrough cancer treatment to be available in India 1st time as CAR-T cell therapy gets DCGI nod

Therapy developed by IIT-Bombay spin-off company ImmunoACT approved for relapsed-refractory B-cell lymphoma, leukemia, to be available in around 20 govt & pvt hospitals across major cities.

Calls for caution over phenylephrine’s efficacy, as FDA panel deems decongestant ineffective

Panel report notes that oral phenylephrine is no better than placebo for relieving nasal congestion. In India, phenylephrine is widely used in cough and cold medicines.

Kerala doctors & researchers plan India’s 1st private drug quality assessment drive

Project follows outcry over NMC rule, now on hold, asking medical practitioners to prescribe generics or face penalty. Dr Cyriac Abby Philips or ‘@TheLiverDoc’ part of project.

After WHO alert, drug controller general warns against use of cough syrups containing pholcodine

Pholcodine is used to treat dry cough. WHO had flagged risk of anaphylactic reactions in those who took remedies containing Pholcodine at least 12 months prior to surgery.

On Camera

Delhi is keeping Dhaka’s security concerns in mind. Tarique Rahman should remember this

India-Bangladesh ties can only improve if there is a new, clean slate. The two need to respect each other’s trigger lines.

Blow to West Asia commodities market as Iran hits 2 aluminium makers

Aluminum prices, already rising before the conflict, have gained further as traders and buyers focus on the potential for tighter markets and shrinking global inventories.

1st batch of 2,000 India-made Israeli Negev LMGs delivered to Army; 4,000 more to be delivered this year

The Indian Army is set to get another 4,000 of these LMGs as part of a contract signed in August 2024 to replace the 5.56x45mm INSAS LMG.

Gulf war exposed India’s fragilities. It’s time for navel-gazing, in the national interest

It’s easy to understand why the government can’t speak the hard truth. When this war ends, as all wars do, India’s interests will lie with both the winner and the loser.